study of imc-11f8 in participants with colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to determine if imc-11f8 in combination with chemotherapy is effective in treating colorectal cancer (crc).

the purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (egfr) monoclonal antibody imc-11f8 administered in combination with mfolfox-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic crc participants.

Eligibility criteria:
inclusion criteria: * histologically-confirmed, egfr-detectable or egfr-undetectable crc * locally-advanced unresectable or metastatic adenocarcinoma of the colon or rectum * at least 1 unidimensional-measurable target lesion by computed tomography (ct) scan or magnetic resonance imaging (mri); target lesion(s) must not lie within an irradiated area * age ≥18 years * life expectancy of ≥6 months * eastern cooperative oncology group (ecog) performance status ≤2 at study entry * adequate hematologic function, as evidenced by an absolute neutrophil count (anc) ≥1.5 x 10\^9 liter (l), hemoglobin ≥10 grams per deciliter (g/dl), and platelets ≥100 x 10\^9/l * adequate hepatic function as defined by a total bilirubin ≤1.5 milligrams per deciliter (mg/dl), aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤2.5 x upper limit of normal (uln) (or 5.0 x uln in the case of liver metastases), and alkaline phosphatase (ap) ≤2.5 x uln (or 5.0 x uln in the case of liver metastases) * adequate renal function as defined by a serum creatinine ≤1.5 x uln, creatinine clearance ≥ 60 milliliters per minute (ml/min), or serum albumin ≥lower limit of normal (lln) * participant's relevant toxicities/effects of prior therapy \[surgery/radiation therapy (rt)\] must have recovered to a stable or chronic level * participant agrees to use adequate contraception during the study period and for 4 weeks after the last dose of study treatment. participants must notify the principal investigator if they themselves or their partner becomes pregnant. * participant has provided signed informed consent exclusion criteria: * has received prior systemic chemotherapy for locally-advanced unresectable or metastatic crc. * has received prior radiotherapy to \>25% of bone marrow * has documented and/or symptomatic brain metastases * has participated in clinical studies of non-approved experimental agents or procedures within 12 weeks of study entry * has received previous therapy with monoclonal antibodies * has received previous therapy with any agent that targets the egfr * has serious concomitant medical conditions including active uncontrolled infection or cardiac disease, which in the opinion of the investigator, could compromise the participant or study. * on chronic non-topical corticosteroid treatment for \>6 months at doses \>10 milligrams per day (mg/day) of prednisolone or equivalent before study entry, which in the opinion of the investigator could compromise the participant or the study * has a known dihydropyrimidine dehydrogenase deficiency * has a known allergy to any of the treatment components * has an acute or subacute intestinal occlusion * has peripheral neuropathy ≥grade 2 * has a history of other malignancies, with the exception of curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix * if female, is pregnant (confirmed by urine or serum beta human chorionic gonadotropin test) or breast-feeding * has received a prior autologous or allogeneic organ or tissue transplantation * has interstitial pneumonia or interstitial fibrosis of the lung * has pleural effusion or ascites that causes ≥grade 2 dyspnea * has psychological, familial, sociological, or geographical conditions which do not permit adequate study follow-up, compliance with the protocol, or signature of informed consent

Keywords: antibodies, monoclonal colorectal neoplasms